MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ TRANSRAD KIT 11CM; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 504616Z

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

Event Description

As reported, placement of 6f 11cm avanti sheath introducer with mini-guidewire was difficult and the patient felt pain after successful puncture.It was found that the catheter sheath had a ¿burr¿ when removed from the patient.A new unknown catheter sheath was used, and the procedure was completed.There was no reported patient injury.The patient had no pain and the follow up operation went smoothly.The device was used for a coronary angiography procedure.It is unknown if the device will be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18023669 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.As reported, placement of 6f 11cm avanti sheath introducer with mini-guidewire was difficult and the patient felt pain after successful puncture.It was found that the catheter sheath had a ¿burr¿ when removed from the patient.A new unknown catheter sheath was used, and the procedure was completed.There was no reported patient injury.The patient had no pain and the follow up operation went smoothly.The device was used for a coronary angiography procedure.The product was not returned for analysis.A product history record (phr) review of lot 18023669 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer events ¿catheter sheath introducer (csi)- insertion difficulty¿ and ¿catheter sheath introducer (csi)- foreign material¿ could not be confirmed.Procedural and/or handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.If increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi.Remove csi from package using sterile technique.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: SI AVANTI+ TRANSRAD KIT 11CM
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; santiago troncoso 808; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15129256
• MDR Text Key: 298282934
• Report Number: 9616099-2022-05860
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032010283
• UDI-Public: 10705032010283
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 504616Z
• Device Catalogue Number: 504616Z
• Device Lot Number: 18023669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER SHEATH